Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

Cancer Clinical Trial

Official title:

Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292655
• Other study ID #: CA216-001
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2011
• Est. completion date: June 22, 2017

Study information

• Verified date: January 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation

• Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion

• Biopsy accessible tumor (may be waived under certain circumstances)

• Life expectancy of at least 3 months

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Adequate organ and bone marrow function

Exclusion Criteria:

• Infection

• Elevated triglycerides

• Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]

• Taking medications known to increase risk of Torsades De Pointes

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• BMS-906024

Locations

Country	Name	City	State
Australia	Local Institution	Parkville	Victoria
Canada	Local Institution	Toronto	Ontario
United States	Winship Cancer Institute.	Atlanta	Georgia
United States	Wayne State University	Detroit	Michigan
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	University Of Mississippi Medical Center	Jackson	Mississippi
United States	Anthony El-Khoueiry, Md	Los Angeles	California
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events as a measure of safety and tolerability		Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year
Secondary	Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1		Tumor assessments at least every 8 weeks during treatment period
Secondary	PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies		PD changes from baseline during the first 4-5 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)		PK at multiple time points during the first 8 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)		PK at multiple time points during the first 8 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)		PK at multiple time points during the first 8 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)		PK at multiple time points during the first 8 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)		PK at multiple time points during the first 8 weeks of dosing
Secondary	PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)		PK at multiple time points during the first 8 weeks of dosing

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form